Label: HAND SANITIZER gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 10, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Ethyl Alcohol 70%

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    For hand sanitizing to decrease bacteria on the skin, kills99% common germs

  • Warnings

    Flammable: Keep away from flame or high heat.

    For external Use only;

  • When use this product

    When use this product avoid contact with the eyes.

  • Stop use

    Stop use and ask a doctor if irritation or redness develop

  • Keep out of reach of children.

    Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away.

  • Directions

    Rub a dime sized drop into hands

  • Inactive Ingredient

    Aqua,Glycerin,Triethanolamine ,carbomer,vitamin E,Aloe Vera

  • Package Label

    Hand Sanitizer

    29ml

    NDC: 74835-001-01 29ml label

  • Package Label

    Hand Sanitizer

    30ml

    NDC: 74835-001-02 30ml label

  • Package Label

    Hand Sanitizer

    59ml

    NDC: 74835-001-03 50ml label

  • Package Label

    Hand Sanitizer

    60ml

    NDC: 74835-001-04 60ml label

  • Package Label

    Hand Sanitizer

    300ml

    NDC: 74835-001-05 300ml label

  • Package Label

    Hand Sanitizer

    500ml

    NDC: 74835-001-06 500ml label

  • Package Label

    Hand Sanitizer

    29ml

    NDC: 74835-002-01

    62 alcohol 29ml label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74835-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74835-002-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/20/2020
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74835-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74835-001-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    2NDC:74835-001-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    3NDC:74835-001-0359 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    4NDC:74835-001-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    5NDC:74835-001-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    6NDC:74835-001-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/20/2020
    Labeler - Hangzhou Lookon Commodity Co., Ltd (541760483)
    Registrant - Hangzhou Lookon Commodity Co., Ltd (541760483)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Lookon Commodity Co., Ltd541760483manufacture(74835-001, 74835-002)